Lead R&D Engineer
Posted 2 weeks ago by Real
£60 Per hour
Undetermined
Hybrid
Northern Ireland
Summary: The Lead R&D Engineer role focuses on the development of next-generation catheter-based medical devices, requiring an experienced engineer with a biomedical or mechanical background. The position involves leading R&D activities, ensuring compliance with design controls, and collaborating with cross-functional teams. The ideal candidate will have a strong track record in the medical device industry and experience in catheter design and development.
Key Responsibilities:
- Lead end-to-end R&D activities for catheter systems, from concept through to design transfer.
- Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 design control requirements.
- Develop and review technical drawings and documentation using AutoCAD.
- Collaborate with cross-functional teams (Quality, Regulatory, Manufacturing).
- Conduct design verification and validation (V&V) activities.
- Support risk management processes including FMEA and hazard analysis.
- Mentor junior engineers and contribute to technical leadership.
Key Skills:
- Degree in Biomedical Engineering, Mechanical Engineering, or related field.
- 6-8+ years of R&D experience in the medical device industry, ideally with large global manufacturers.
- Proven experience in catheter design and development.
- Proficiency in AutoCAD.
- Strong understanding of design controls and regulatory compliance.
- Excellent communication and leadership skills.
Salary (Rate): £60.43/hour
City: Connacht
Country: Ireland
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Lead R&D Engineer - Medical Devices
Location: Connacht in Ireland Hybrid (3 Days Onsite)
Contract: 12-Month
Overview:
We are hiring a Lead R&D Engineer to drive the development of next-generation catheter-based medical devices. This role is ideal for an experienced engineer with a biomedical or mechanical background, strong knowledge of design controls, and a track record in global medtech environments.
Key Responsibilities:
- Lead end-to-end R&D activities for catheter systems, from concept through to design transfer.
- Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 design control requirements.
- Develop and review technical drawings and documentation using AutoCAD.
- Collaborate with cross-functional teams (Quality, Regulatory, Manufacturing).
- Conduct design verification and validation (V&V) activities.
- Support risk management processes including FMEA and hazard analysis.
- Mentor junior engineers and contribute to technical leadership.
Requirements:
- Degree in Biomedical Engineering, Mechanical Engineering, or related field.
- 6-8+ years of R&D experience in the medical device industry, ideally with large global manufacturers.
- Proven experience in catheter design and development.
- Proficiency in AutoCAD.
- Strong understanding of design controls and regulatory compliance.
- Excellent communication and leadership skills.
Contract Details:
Duration: 12 months (with potential for extension)
Work Model: 3 days onsite / 2 days remote
Start Date: Immediate
Rate: Competitive, based on experience
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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC(phone number removed) England and Wales